Lung Transplant SurgeryEVOLUTIONNCT07361718
Comparison Between Two Medical Devices for the Reconditioning of Lungs Intended for Transplantation
A study testing ex vivo lung perfusion for eventual lung transplant and Organ Care system in people with Lung Transplant Surgery, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
This study aims to evaluate the effectiveness of two medical devices ( XPS XVIVO and OCS Transmedics) used for organ reperfusion in patients needing bilateral lung transplants from marginal donors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Transplant Surgery
- What is being tested?
- ex vivo lung perfusion for eventual lung transplant and Organ Care system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2026to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age greater than 18 years
- informed consent
- donor with at least one of the following: age greater than 55 years P/F on evaluation less than 350 mmHg smoker (more than 20 p/y) lung atelectasis on chest ct class II and III DCD according to Maastricht classification
Who cannot join
- lung Haematoma or signsd of lung contusion
- signs of infecton of the graft
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Melania MM Milanese, Pharmacy contact
About this study
Official title: Comparison Between Two Medical Devices for the Reconditioning of Lung Grafts: Pilot Study EVOLUTION (Ex viVO Lung perfUsion for Lung Transplantation)
This study aims to evaluate the effectiveness of two medical devices ( XPS XVIVO and OCS Transmedics) used for organ reperfusion in patients needing bilateral lung transplants from marginal donors.
Read the detailed description
Marginal organs, which do not have ideal transplant characteristics but are not rejected, can be treated with ex-vivo reperfusion and reventilation machines to optimize their condition. The two main devices studied are:
Organ Care System (OCS) Transmedics, a mobile machine for use at the donor site.
XPS XVIVO, a static machine used for organs transported with cold preservation. The study's primary objective is to assess the acceptance rate of organs treated with these devices, while secondary objectives include comparing the duration of mechanical ventilation, ECMO use, and 90-day survival rates in transplanted patients.
- Conditions
- Lung Transplant Surgery
- Being tested
- ex vivo lung perfusion for eventual lung transplant, Organ Care system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ex vivo lung perfusion for eventual lung transplantDevice
ex vivo lung repefusion to evaluate lung function
Organ Care systemDevice
organ care system
| Study group | Role | What they receive |
|---|---|---|
| OCS | Experimental | Not described Receives: Device: Organ Care system |
| X vivo | Experimental | Not described Receives: Device: ex vivo lung perfusion for eventual lung transplant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptance rate to transplant
Measured: after the transplant
Secondary outcomes (3)
days on mechanical ventilation
Measured: from transplant moment since the day weaning from mechanical ventilation
duration on postoperative ECMO (ExtraCorporeal Membrane Oxygenation)
Measured: from transplant date since the day weaning from ECMO (ExtraCorporeal Membrane Oxygenation)
mortality
Measured: within 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study startJan 2026 (estimated)
- Primary completionJan 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Transplant SurgeryStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Filippo Antonacci, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07361718
- Sponsor's protocol ID
- 697/2024/Disp/AOUBo
- Acronym
- EVOLUTION
- Status last verified
- Dec 2025
- First submitted
- 21 Nov 2025
- Last updated
- 23 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Two Medical Devices for the Reconditioning of Lung Grafts: Pilot Study EVOLUTION (Ex viVO Lung perfUsion for Lung Transplantation)
- ClinicalTrials.gov ID
- NCT07361718
- Acronym / sponsor ID
- EVOLUTION / 697/2024/Disp/AOUBo
- Conditions
- Lung Transplant Surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 23 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the effectiveness of two medical devices ( XPS XVIVO and OCS Transmedics) used for organ reperfusion in patients needing bilateral lung transplants from marginal donors.
Detailed description
Marginal organs, which do not have ideal transplant characteristics but are not rejected, can be treated with ex-vivo reperfusion and reventilation machines to optimize their condition. The two main devices studied are:
Organ Care System (OCS) Transmedics, a mobile machine for use at the donor site.
XPS XVIVO, a static machine used for organs transported with cold preservation. The study's primary objective is to assess the acceptance rate of organs treated with these devices, while secondary objectives include comparing the duration of mechanical ventilation, ECMO use, and 90-day survival rates in transplanted patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OCS | Experimental | Device: Organ Care system |
| X vivo | Experimental | Device: ex vivo lung perfusion for eventual lung transplant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age greater than 18 years
- informed consent
- donor with at least one of the following: age greater than 55 years P/F on evaluation less than 350 mmHg smoker (more than 20 p/y) lung atelectasis on chest ct class II and III DCD according to Maastricht classification
Key exclusion criteria (2 listed)
- lung Haematoma or signsd of lung contusion
- signs of infecton of the graft
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ex vivo lung perfusion for eventual lung transplantex vivo lung repefusion to evaluate lung function | Device | X vivo |
| Organ Care systemorgan care system | Device | OCS |
Primary outcome
Acceptance rate to transplant
Time frame: after the transplant
3 secondary outcomes
days on mechanical ventilation
Time frame: from transplant moment since the day weaning from mechanical ventilation
duration on postoperative ECMO (ExtraCorporeal Membrane Oxygenation)
Time frame: from transplant date since the day weaning from ECMO (ExtraCorporeal Membrane Oxygenation)
mortality
Time frame: within 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Melania MM Milanese, Pharmacy contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ex vivo lung perfusion for eventual lung transplant and Organ Care system in people with Lung Transplant Surgery, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Filippo FA Antonacci, MD (+390512145593, filippo.antonacci@aosp.bo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptance rate to transplant (time frame: after the transplant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.